Method and apparatus for a process creating an internal tissue graft for animal and human reconstructive purposes

ABSTRACT

A method and apparatus is provided for creating an internal reconstruction tissue graft. Templates may be used to create a multitude of patterns in a variety of tissue reconstruction grafts. An apparatus may be used to create an internal tissue graft for reconstruction through either compression and/or removal of segments. An apparatus may be used, through either compression and or removal of segments of a preformed template made of synthetics and or metal that mirrors a template that can be used as an internal tissue graft for reconstruction. In a method, such as using software analysis and an apparatus, the physical properties of the tissue graft and its pre- and post-operative properties and appearance may be measured.

RELATED APPLICATION DATA

This application is a continuation of U.S. patent application Ser. No.13/101,022, filed May 4, 2011, and claims priority to U.S. ProvisionalApplication Ser. No. 61/331,805, filed May 5, 2010.

FIELD OF THE INVENTION

The present invention relates to a device and method creating a novelsurgical internal reconstruction tissue graft by creating templatedesigns on internal reconstructive grafts and measuring their physicalproperties.

BACKGROUND OF THE INVENTION

Current surgical reconstruction of internal tissue defects utilizes asolid, porous sheet with or without perforations. Current grafts allowfor perforations that do enhance fluid egress and in growth of newtissue but due to the constrictive nature of such tissue grafts, theincidences of recurrences and the inability to expand with theapplication of increased pressure has allowed for a significantincidence of recurrence, stress tears, and an inability for expansionused in reconstructive and aesthetic procedures. Current tissue graftsalso do not allow for the ability to enhance traction between the graftand specific anatomic points, similar in physical properties of howspecific tread designs enhance traction between the tire and the roadsurface, as well as increase the time of utilization of the tire. Thecurrent novel invention applies these engineering applications toachieve similar results to internal surgical tissue grafts. None of thereferences below discuss the advantages of utilizing the current methodand apparatus of applying designs and templates to internal surgicalreconstructive grafts.

BRIEF DESCRIPTION OF THE FIGURES

FIGS. 1A and 1B illustrate a top and bottom, respectively, of a tissuegraft having patterns in accordance with the invention; and

FIG. 2 is a side view of a tissue graft having various adhesion,expansion and through-hole features in accordance with the invention.

SUMMARY OF THE INVENTION

A method and apparatus for creating an internal reconstruction tissuegraft is disclosed. In one embodiment, the method and apparatuscomprises the following components and variations thereof: 1) a methodfor the creation of templates used to create a multitude of patterns ina variety of tissue reconstruction grafts; 2) an apparatus that througheither compression and or removal of segments of tissue create theinternal tissue graft for reconstruction; 3) an apparatus that througheither compression and or removal of segments of a preformed template(such as made of synthetics and or metal) that mirrors a template thatcan be used as an internal tissue graft for reconstruction; and/or 4) amethod of measuring, through software analysis and an apparatus, thephysical properties of the tissue graft and its pre and post-operativeproperties and appearance.

The purpose in creating a template with variable and multiple patternsthroughout a single sheet preferably enables the tissue graft and itsincorporation in an anatomic area.

In one embodiment, the invention is configured to, and an advantage ofthe invention comprises, reducing stress in grafts subject to continuousmotion, such as, in the knee, hip, and cervical regions

In one embodiment, the invention is configured to, and an advantage ofthe invention comprises, reducing stress in grafts subject to increasedpressure gradients such as in the abdominal wall, inguinal hernia, andarterial grafts.

In one embodiment, the invention is configured to, and an advantage ofthe invention comprises, allowing for selective expandability (such asvia partial or non-through expansion incisions and/or through expansionincisions of various thicknesses in the graft) in order to achievebetter contour and external appearance.

In one embodiment, the invention is configured to, and an advantage ofthe invention comprises, allowing for selective expandability (such asvia partial or non-through expansion incisions and/or through expansionincisions of various thicknesses in the graft) in order to achievebetter outflow of blood in venous grafts.

In one embodiment, the invention is configured to, and an advantage ofthe invention comprises, allowing for selective traction or adhesionpoints of tissue grafts to key anatomic areas when needed in order toincrease fixation at insertions and origins to reduce slippage of thegraft.

In one embodiment, the invention is configured to, and an advantage ofthe invention comprises, promoting vascular in growth of the body'stissue in specific areas of the internal tissue graft.

In one embodiment, the invention is configured to, and an advantage ofthe invention comprises, allowing for an increase in the period of timeof utilization and longevity of the internal reconstructive graft.

Further objects, features, and advantages of the present invention overthe prior art will become apparent from the detailed description of thedrawings which follows, when considered with the attached figures.

DETAILED DESCRIPTION OF THE INVENTION

One embodiment of the invention comprises a method of creating templatesused to create a multitude of patterns in a variety of tissuereconstruction grafts. Such may consist of pre- or intra-operativelymade templates.

In one embodiment, the templates may be based on software analysis of aninitial tissue defect, the template designed to allow for a desiredgraft pattern to reduce the potential pressure, reduce stress, decreasewear and tear, and/or provide traction between a created graft andspecific anatomic points. Based on factors such as, but not limited to,the size, shape, thickness, width, variegations, type, and the desiredsurgical outcome, a pattern may be created within the internal tissuegraft. Due to the variability in a defect being reconstructed, such asthe Abdominal Wall, Breast, Face, and Extremities, different templatepatterns may be generated. Software analysis may be used to create anappropriate internal tissue graft for an identified existing defect.

In one embodiment, different materials may be used to make the templatesand their respective patterns. Currently external reconstructivetemplates use a mesh pattern with expansion ranging from 1 to 2, 1 to 4,1 to 8 etc. In a preferred embodiment of the invention, internalreconstruction grafts may be created which not only permit meshexpansion, but provide for a multitude of various designs, shapes,patterns, variegations and materials to accommodate the existing defectto achieve the desired reconstructive and aesthetic results.

In one embodiment, software and/or hardware may be used to perform apre-operative analysis. Templates may be constructed from a pre-mademold, and be made of different materials such as metal or plastic to beintegrated with a compression device. The template can be integratedwith a stationary or portable compression apparatus that can createprepackaged tissue grafts to be subsequently sterilized to be used by asurgeon in the operating room, or portable temples and compressiondevices can be used in a sterile operation room, or an apparatus mayallow a surgeon to incise predetermined patterns into the tissue graftsby a knife or other cutting implement. A primary objective of theinvention allows for newly created internal patterned tissue grafts toaccommodate anticipated problems due to any and all activity andreconstructive and aesthetic results.

In one embodiment, an apparatus, either via compression and/or removalof segments of tissue, creates an internal tissue graft forreconstruction by creating a desired pattern within an internal tissuegraft. Compression can be used against the template that in turn createsthe desired internal pattern.

In a second methodology, pre-designed patterns of tissue mirror thespecific designs on a pre-formed template that can be subsequently usedon a portable compression and punch apparatus that can used to createthe internal tissue graft in the operating room. Additional techniquesusing an apparatus that uses laser cutting technology can be utilized.

For example, FIG. 2 illustrates a tissue graft 20 where compressionand/or removal of segments (such as spaced or separated by variousdistances between them) create recessed expansion patterns of variousdepths and shapes 22, adhesion projections of various heights and shapes24 and through holes 26. FIGS. 1A and 1B illustrate one example ofpatterns of adhesion features 22 and expansion features 24 relative to atop (in FIG. 1A) and bottom (in FIG. 1B) of a tissue graft 20, whichpatterns may be used to generate a tissue graft having particulardesired characteristics for a particular application.

Current medical devices are not applicable for creating the multitude ofdesired pattern grafts for each defect. In accordance with theinvention, an apparatus can be used to create patterns applicable to aspecific tissue defect, whether pre- or intra-operatively.

Measuring, such as through software analysis and an apparatus, thephysical properties of the tissue graft and its pre- and post-operativeappearance may be utilized to correlate the physical properties of acreated internal tissue graft and desired reconstructive and aestheticgrafts.

Broadly the present invention is directed to methods, apparatus, anddevices involving variable templates for the purpose of internalreconstruction of body tissues including, but not limited to, a breast,the abdominal wall, vascular, and extremities. In a first method inaccordance with the present invention, a template is created that allowsfor increased flexibility as it relates to the graft, and subsequentlythe need to contouring to sling a breast implant used in achieving anatural result for the patient. The template is pre-made or createdduring the reconstruction procedure to enhance the physical propertiesof the internal tissue graft to meet the requirements of the tissuegrafts expectations, whether it is enhanced expansion, flexibility,traction, or period of utilization in anatomic areas where it is placed.

The above description represents one embodiment of the presentinvention. However, many variations to the method and apparatus arepossible without deviating from the scope of the invention. It will beunderstood that the above described arrangements of apparatus and themethod described herein are merely illustrative of applications of theprinciples of this invention and many other embodiments andmodifications may be made without departing from the spirit and scope ofthe invention as defined in the claims.

What is claimed is:
 1. A method of using one or more templates to create an anatomically designed reconstructive tissue constructive graft for implantation at an anatomical site of a human body, comprising the steps of: (a) collecting information regarding characteristics of an anatomical site of a human body at which an internal tissue graft is needed; (b) determining desired characteristics of a reconstructive tissue graft for said anatomical site from said collected information; (c) obtaining a tissue graft from a location different than said anatomical site; and (d) utilizing a template to create a reconstructive tissue graft by compressing, cutting or removing portions of said tissue graft using said template to change a natural surface of a tissue graft to include a plurality of different surface patterns which cause said reconstructive tissue graft to have said desired characteristics for said anatomical site.
 2. The method according to claim 1, wherein said tissue graft comprises human tissue.
 3. The method according to claim 1, wherein said tissue graft comprises cellular non human tissue, including cellular and acellular processed grafts.
 4. The method according to claim 1, wherein said tissue graft comprises one or more synthetic materials.
 5. The method according to claim 1, wherein at least one of said plurality of different surface patterns is configured to permit the egress of fluid from said anatomical site.
 6. The method according to claim 1, wherein said tissue graft has a thickness and wherein said plurality of different surface patterns may be either full thickness or partial thickness.
 7. The method according to claim 1, wherein said tissue graft has an anterior surface and a posterior surface and said plurality of surface patterns are associated with both said anterior and posterior surfaces.
 8. The method according to claim 1, wherein at one least one of said plurality of different surface patterns is configured to permit controlled expansion of said reconstructive tissue graft.
 9. The method according to claim 1, wherein at least one of said plurality of different surface patterns is configured to provide enhanced stress relief during motion of and reduction of internal pressure on the reconstructive tissue graft.
 10. The method according to claim 1, wherein at least one of said plurality of different surface patterns is configured to provide enhanced adhesion between the reconstructive tissue graft and tissue at said anatomical site.
 11. The method according to claim 1, wherein at least one of said plurality of different surface patterns is configured to provide enhanced retention of various medicants and materials.
 12. The method according to claim 1, wherein at least one of said plurality of different surface patterns comprises variegations.
 13. The method according to claim 1, wherein at least one of said plurality of different surface patterns is configured to facilitate placement by sutures or staples of the reconstructive tissue graft at said anatomical site.
 14. A method for creating an pre configured anatomically designed reconstructive tissue graft for implantation at an anatomical site of a human body, comprising the steps of: (a) collecting information regarding characteristics of an anatomical site of a human body at which an internal tissue graft is needed; (b) determining desired characteristics of a reconstructive tissue graft from said collected information; (c) obtaining a tissue graft from a location different than said anatomical site; and (d) utilizing an apparatus having a configuration which is dependent upon said desired characteristics to compress, cut or remove portions of said tissue graft to change a natural surface of said tissue graft to create a reconstructive tissue graft having a plurality of different surface patterns, said surface patterns designed to enhance retention of medicants and materials.
 15. The method according to claim 14, wherein said tissue graft comprises human tissue.
 16. The method according to claim 14, wherein said tissue graft comprises cellular non human tissue, including cellular and acellular processed grafts.
 17. The method according to claim 14, wherein said tissue graft comprises one or more synthetic materials. 